What are procedures for inspection and classification of Good Manufacturing Practices for pharmaceutical products and pharmaceutical starting materials (GMP) compliance in Vietnam?

What are procedures for inspection and classification of Good Manufacturing Practices for pharmaceutical products and pharmaceutical starting materials (GMP) compliance in Vietnam? - image from internet

Pursuant to Article 7 of the Circular 35/2018/TT-BYT on Good Manufacturing Practices for pharmaceutical products and pharmaceutical starting materials by the Minister of Health stipulating procedures for inspection and classification of GMP compliance in Vietnam:

1. Principles of using GMP documents for inspection of GMP compliance:

a) GMP documents are applied by the manufacturer and specified in the application form for certificate of eligibility for pharmacy business.

b) EU - GMP or PIC/S - GMP or GMP documents specified in Clause 3 Article 3 of this Article are applied if the manufacturer has undergone GMP inspection by SRA and been recommended by SRA to make the declaration of compliance with GMP.

c) WHO - GMP or GMP documents specified in Clauses 2, 3, 4, 5 and 6 Article 4 of this Circular are applied if the manufacturer does not specify applied GMP principles in the application form for certificate of eligibility for pharmacy business.

2. Inspection procedures:

a) Step 1. The inspectorate shall publish the decision on inspectorate establishment, purposes, contents and plan for the inspection at the manufacturer;

b) Step 2. The manufacturer shall make a brief introduction of its organizational structure, personnel and implementation or application of GMP, or specific contents in conformity with the inspected contents;

c) Step 3. The inspectorate shall carry out a site inspection of the application of GMP at the manufacturer. If the manufacturer enters one or some stages of the manufacturing process, only GMP applied to such stages is inspected.

d) Step 4. The inspectorate shall have a talk with the manufacturer about deficiencies found during the inspection (if any) and assess the level of each deficiency; discuss with the manufacturer in case the manufacturer does not agree with the inspectorate about the assessment of each deficiency or level of GMP compliance;

dd) Step 5. An inspection record is prepared and signed as follows:

After the site inspection, the inspectorate shall make an inspection record using the Form No. 03 in the Appendix X hereof. It shall clearly specify members of the inspectorate and the manufacturer, location, date and scope of the inspection and disagreements (if any) between the inspectorate and the manufacturer. It shall be signed by the head of the manufacturer and chief of the inspectorate. The record shall be made into 03 copies, among which one is kept by the manufacturer and the others are kept by the receiving authority.

e) Step 6. The inspection record is completed as follows:

The inspectorate shall make a GMP inspection report using the Form No. 04 in the Appendix X hereof, list, analyze and classify deficiencies that need to be rectified by the manufacturer, make a comparison of corresponding regulations specified in legal documents and GMP, and assess the level of GMP compliance. The deficiency classification and assessment of level of GMP compliance (applied to each production line) are prescribed in the Appendix IX hereof.

3. Level of GMP compliance:

The inspection of manufacturer's compliance with GMP specified in Appendix IX hereof shall be carried out according to the following 04 levels:

a) GMP level 1 manufacturer;

b) GMP level 2 manufacturer;

c) GMP level 3 manufacturer;

d) GMP level 4 manufacturer.

Above are procedures for inspection and classification of GMP compliance in Vietnam. Please refer to the Circular 35/2018/TT-BYT for further information.

Best regards!